E8-16777. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, HHS.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Withholding Medicare Payments to Recover Medicaid Overpayments and Supporting Regulations in 42 CFR 44.31; Use: Overpayments may occur in either the Medicare and Medicaid program, at times resulting in a situation where an institution or person that provides services owes a repayment to one program while still receiving reimbursement from the other. Certain Medicaid providers which are subject to offsets for the collection of Medicaid overpayments may terminate or substantially reduce their participation in Medicaid, leaving the State Medicaid Agency unable to recover the amounts due. These information collection requirements give CMS the authority to recover Medicaid overpayments by offsetting payments due to a provider under the program. Form Number: CMS-R-21 (OMB# 0938-0287); Frequency: On occasion; Affected Public: State, Local or Tribal Governments; Number of Respondents: 54; Total Annual Responses: 27; Total Annual Hours: 81.

2. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Collection of Drug Pricing and Network Pharmacy Data from Medicare Prescription Drug Plans (PDPs and MA-PDs) and Supporting Regulations in 42 CFR 423.48; Use: Both stand alone prescription drug plans (PDPs) and Medicare Advantage Prescription Drug (MA-PDs) plans are required to submit drug pricing and pharmacy network data to CMS and these data are made publicly available to people with Medicare through the Medicare Prescription Drug Plan Finder Web tool on http://www.medicare.gov. Drug prices vary across a plans pharmacy network based on the contracts that each plan negotiates with each pharmacy or pharmacy chain in their networks. The pharmacy networks can change during the course of the year as new pharmacies open, close, change ownership, or plans negotiate new contracts with pharmacies resulting in different dispensing fees for prescriptions. Drug prices also change frequently due to the daily fluctuation of the Average Wholesale Price (AWP), thus plans increase or decrease their drug prices to reflect these changes. The purpose of the data is to enable prospective and current Medicare beneficiaries to compare, learn, select and enroll in a plan that best meets their needs. The database structure provides the necessary drug pricing and pharmacy network information to accurately communicate plan information in a comparative format. Form Number: CMS-10150 (OMB# 0938-0951); Frequency: Bi-weekly; Affected Public: Business or other for-profits; Number of Respondents: 680; Total Annual Responses: 17,680; Total Annual Hours: 70,720.

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Durable Medical Equipment Regional Carrier, Certificate of Medical Necessity for Oxygen and Supporting Regulations in 42 CFR 410.38 and 424.5; Use: The oxygen certificate of medical necessity (CMN) collects information required to help determine the medical necessity of home oxygen therapy for Medicare beneficiaries. CMS requires CMNs where items may present a vulnerability to the Medicare program. Each claim for these items must have an associated CMN for the beneficiary. In order to determine if a beneficiary needs home oxygen therapy, a qualifying blood gas study must be performed and it must comply with the DMERCs Oxygen Medical Policy on the standards for conducting the test and also be covered under Medicare Part B. A beneficiary must be seen and evaluated by the treating physician within specific timeframes as indicated by the Oxygen Medical Policy in order to complete an Initial CMN Certification, a Recertification CMN and a Revised CMN Certification. Form Number: CMS-484 (OMB# 0938-0534); Frequency: Occasionally; Affected Public: Business or other for-profits; Number of Respondents: 15,000; Total Annual Responses: 1,630,000; Total Annual Hours: 326,000.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS's Web Site at http://www.cms.hhs.gov/​PaperworkReductionActof1995,, or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to [e-mail], or call the Reports Clearance Office on [phone].

In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by September 22, 2008:

1. Electronically. You may submit your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) accepting comments.

2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number _____, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Dated: July 11, 2008.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.